Comparative Evaluation of Implant Stability, Soft & Hard Tissue Healing Around UV Activated vs Conventional Implants

August 2, 2024 updated by: Krishnadevaraya College of Dental Sciences & Hospital

Comparative Evaluation of Implant Stability, Soft and Hard Tissue Healing Around UV Activated Versus Conventional Implants - A Randomized Clinical Trial.

Research is to compare and evaluate the primary and secondary implant stability, healing of the soft tissue around UV activated implants and conventional implants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Research is to compare and evaluate the primary and secondary implant stability, healing of the soft tissue around UV activated implants and conventional implants. The objectives are to access the primary and secondary implant stability using Resonance frequency analysis, marginal bone level using RVG with grid, healing of the soft tissue. The control group will be treated with conventional implant and test group will be treated with UV implants. The total number of participants are 12 and 24 sites (control - 12 sites, test - 12 sites) with 3 months follow up.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Karnataka
      • Bengaluru, Karnataka, India, 562157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • At east above 18 years of age
  • Patients who needs replacement for at least 2 missing teeth in the posterior region of mandible
  • Adequate bone volume to accommodate planned dental implants
  • Patients who will comply with oral health care instructions and necessary visits

Exclusion Criteria:

  • General contraindications to dental implant treatment ( uncontrolled diabetes, severe cardiovascular or infectious disease)
  • Intravenous and oral bisphosphonate therapy
  • Unwillingness to return for the follow up examinations
  • Smokers
  • Patients who are psychologically unable to participate
  • Poor oral hygiene

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional dental implant group
conventional dental implant placement will act as control group.
Procedure: conventional implant

A full thickness mucoperiosteal flap was elevated under local anesthesia, osteotomy sites were prepared according to manufacturer's instructions and parallel pin was used to confirm position and angulation of osteotomy site. Conventional implant placement was done on one side.

Resonance frequency analysis instrument was used to measure Implant Stability Quotient (ISQ) and check the primary stability of the implant. The surgical wound closure was done with mattress and single interrupted sutures, using 4-0 vicryl sutures.
Experimental: UV dental implant group
UV activated implant placement will act as test group which has better osseointegration properties.
Procedure: UV implant

A full thickness mucoperiosteal flap was elevated under local anesthesia and osteotomy sites were prepared according to manufacturer's instructions. Parallel pin was used to confirm position and angulation of osteotomy site. UV implant was activated using UV Activator2 and placed in another site.

Resonance frequency analysis instrument was used to measure Implant Stability Quotient (ISQ) and primary stability of the implant was measured. The surgical wound closure was done with mattress and single interrupted sutures, using 4-0 vicryl sutures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability using Resonance Frequency Analysis
Time Frame: "Immediately after Post-operative", "1 month", "3 months"
to measure primary and secondary stability
"Immediately after Post-operative", "1 month", "3 months"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal bone loss using RVG with grid
Time Frame: "Immediately after Post-operative", 3 months
to measure marginal bone level
"Immediately after Post-operative", 3 months
Soft tissue healing
Time Frame: 1 week, 1 month, 3 months.
soft tissue healing to be assessed using Landry Turnbull and Howley Healing Index. Soft tissue healing will be scored from 1 to 5, where score 1 is very poor and 5 is excellent.
1 week, 1 month, 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

March 25, 2026

Study Completion (Estimated)

March 25, 2026

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 02_D012_00048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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